photo credit: BWJones
If you look at the technology that's coming down the pike, it's nothing short of astonishing. A biotech company in South Korea is developing a breathalyser that can detect the non-invasive forms of the breast cancer in its early stages. A small study of seventy women (35 with and 35 without the disease) showed promise.
Trauma Pod is a self-contained suite of robots that allow emergency surgery by remote control. It's a perfect fit for places like Afghanistan, where severely wounded IED victims can bleed out during an airlift to a field hospital. The robots in the Trauma Pod will keep the patient's airway clear, stop any life-threatening bleeding, and take CT scans for diagnosis. This is not sci-fi but is slated for full production in the next two or three years.
Another device - Deep Bleeder Acoustic Coagulation or DBAC - is a powered cuff that wraps around a patient's limb, and uses ultrasound to both find and tie of bleeding arteries without human assistance. It's coming in the next few years.
Given the promise of devices like these, you might wonder just what we have to be worried about. Unfortunately, the answer is more than you might realize.
Each year, the Emergency Care Research Institute or ECRI puts out a list of Top Ten Tech Hazards in health care. Several medical devices made the latest list. The number three hazard on the list is medication dosage mistakes made using devices known as infusion pumps. These devices deliver everything from narcotics for pain relief to cancer chemo to antibiotics. The US Food and Drug Administration and the Institute for Safe Medicine Practice Canada have received numerous reports of adverse events associated with the use of infusion pumps, including serious injuries and deaths.
As reported by the US Food and Drug Administration, in that country, between 2005 and 2009, 87 infusion pump recalls were conducted by firms to address identified safety problems. Also on the list of top ten tech hazards in health care: medical devices meant for patients to use at home. The problem is that many of these devices are very difficult for patients to master.
There are certainly examples of medical devices that are fundamentally flawed. But it's also true that in many cases, the problem lies not just with the technology but the ways in which health professionals interact with the technology. In 2006, an Alberta woman died of an overdose of chemo. According to an analysis of the events that took place, one of the most important factors in the woman's death was that the nurses had trouble programming the infusion pumps; due to a programming error, the patient got full dose of chemo over four hours instead over four days.
Number one on that top ten list I was talking about are alarm hazards including alarm fatigue. TV medical dramas are full of heart machines that sound the alarm. Studies show the more alarms like these ring out, the more doctors and nurses ignore them. Alarm fatigue has reportedly led to patient deaths.
There's unintentional harm. Then again, there's harm caused by malicious intent. I'm not aware of any actual cases of patients being deliberately harmed but the potential is certainly there. Late last year, medical device maker Medtronic asked software-security experts to investigate the safety of its insulin pumps after a new claim reportedly surfaced that at least one of its devices could be hacked to dose diabetes patients with potentially lethal amounts of insulin.
Acording to reports, a research team at Intel Corp.'s McAfee said it has developed code that allowed it to gain complete control of the functions of one Medtronic insulin pump model from as far away as 300 feet - putting anyone who uses such a device at risk. And it's not just insulin pumps we're talking about. Experts believe that pacemakers, implantable defibrillators (ICDs), and neurostimulators are also vulnerable.
Given issues like these, what's being done to protect the public? Until quite recently, you could say that pharmaceutical drugs were far more regulated than medical devices. That's changing, albeit slowly. Last June, the Auditor General issued a report on the job Health Canada is doing regulating medical devices. Among the main conclusions: more than 45 percent of the time Health Canada does not meet its service standards for timely review of medical device submissions, thus delaying Canadians' access to the health benefits of these devices. As well, Health Canada has not established what levels of activity are needed to protect the health and safety of Canadians. In addition, while the Department has identified risks associated with medical devices already available on the Canadian market, it has yet to determine whether the risks that the inspections and the review of incident reports are designed to address have been adequately reduced.
As we have seen all too often with pharmaceutical drugs, along with benefit comes risk. The same can certainly be said for medical devices. My advice is to look forward to emerging benefits but stay vigilant for inevitable problems.